1,2-Propanediamine, N1-(2-aminoethyl)-3-(4-ethoxyphenyl)-, hydrochloride (1:2), (2S)-

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

no

Principles of method if other than guideline:

In considersation of the relevance of granulometry on toxicological assessment, only the size distribution of the sieved fraction <100 ¿m were studied in detail.

GLP compliance:

no

Type of method:

determination of fibre length and diameter distributions

Type of distribution:

counted distribution

Mass median aerodynamic diameter:

16.5 µm

Percentile:

D50

Mean:

16.5 µm

Remarks on result:

other: No standard deviation

Result: Sieve Fraction:

- weighted sample: 1.0088 g

- weight fraction <100 µm: 0.1738 g

- mass fraction <100 µm: 17.23 %

The mass fraction <100 µm was 17.23 %, and was investigated by scanning electron microscopy.

The median diameter (mass fraction) of the particle size is given for the fraction <100 mm. The value 16.50 µm was calculated for spherical and the value 26.17 µm was calculated for cubical particles.

Particle Size	Spherical Volume [%]	Cubical Volume [%]
<4 µm (respirable)	0.00	0.00
4-10 µm (thoracic)	0.12	0.14
10-100 µm (inhalable)	71.99	73.37
>100 µm	27.88	26.49
Median (diameter µm)	16.50	26.17

Conclusions:

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value for the substance of 16.50 µm as spherical particles.

Executive summary:

According to OECD guideline 110, method B, the particle size distribution of the substance was determined by scanning electron microscopy method for the sieved fraction (< 100 µm, 17.23 % of total sample) and presented on the basis of calculated mass fractions. The median diameter was 16.50 µm with two main fractions of 0.12 and 71.99 % distributing in the range of 4 -10 µm and 10 - 100 µm, respectively.

Description of key information

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value for the substance of 16.50 µm as spherical particles.

Additional information

The particle size distribution of the substance was determined according to OECD guideline 110, method B, by scanning electron microscopy method for the sieved fraction (< 100 µm, 17.23 % of total sample) and presented on the basis of calculated mass fractions. The median diameter was 16.50 µm with two main fractions of 0.12 and 71.99 % distributing in the range of 4 -10 µm and 10 - 100 µm, respectively.